BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 3254105 · Received July 30, 2013

    Report

    Report Number
    2210968-2013-15054
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    July 15, 2013
    Report Date
    July 16, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR TENSILE STRENGTH AND THEY MET THE REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A FACELIFT PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE IN HALF WHEN THE KNOT WAS PULLED TAUT. THE NEEDLE REMAINED ON THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354479 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURES - ABSORBABLE GAM ETHICON INC. UNK GEK398

    Patients

    Seq Age Sex Outcome Treatment
    1